Surgeon Center

Information for Surgeons

You play a critical role in their ongoing journey

Speak to your patients with BRAF+ melanoma about the importance of BRAF testing and adjuvant treatment

BRAF testing can help inform treatment decisions

About 50% of patients with melanoma harbor BRAF mutations¹
Patients with stage III BRAF+ melanoma are highly susceptible to relapse²
Nearly 8 of 10 patients with BRAF+ melanoma saw their disease return within 3 years without adjuvant therapy²
- Adjuvant treatment with targeted therapy can help prevent relapse³

Help them get on a path to relapse-free survival immediately following surgery

In COMBI-AD*—For the adjuvant treatment of patients with BRAF V600E/K melanoma and involvement of lymph node(s), following complete resection

52% of patients taking TAFINLAR + MEKINIST were relapse free and alive at 5 years^4-6
- 49% reduction in risk of relapse or death vs placebo at 5 years (hazard ratio [HR], 0.51; 95% CI, 0.42-0.61)
- Results at 48 and 60 months were not prespecified and are observational in nature; as such, there was no prespecified statistical procedure controlling for type 1 error
- In the primary analysis, the median relapse-free survival was not reached in the TAFINLAR + MEKINIST group (95% CI, 44.5-not estimable) and 16.6 months in the placebo group (95% CI, 12.7-22.1); (HR, 0.47; 95% CI, 0.39-0.58; P<.0001)^5,6
86% of patents were alive at 3 years⁴
- Results at 12, 24, and 36 months were not prespecified and are observational in nature; as such, there was no prespecified statistical procedure controlling for type 1 error
- Overall survival (OS) results did not meet the prespecified boundary to claim statistical significance at this first OS interim analysis (P=.000019); median OS had not been reached in either treatment group as of the data cutoff at a median of 2.8 years of follow-up⁴

Offer an adjuvant therapy with an established safety profile with a low risk of irreversible adverse events^3,7,8

Adverse events (AEs) decreased over the 12-month treatment period, and 96% of treatment-related AEs that led to discontinuation of TAFINLAR + MEKINIST in COMBI-AD resolved or were resolving within 30 days of treatment withdrawal^7,8
26% of patients discontinued TAFINLAR + MEKINIST due to an adverse reaction vs 3% with placebo⁴
In COMBI-AD, the most common adverse reactions (≥20%) for the combination were pyrexia (63%), fatigue (59%), nausea (40%), headache (39%), rash (37%), chills (37%), diarrhea (33%), vomiting (28%), arthralgia (28%), and myalgia (20%)^5,6

THE ONLY ORAL THERAPY APPROVED FOR THE ADJUVANT TREATMENT OF BRAF+ V600E/K MELANOMA^5,6,9-12

*COMBI-AD was a phase 3, multicenter, international, randomized (1:1), double-blind, placebo-controlled trial of 870 patients with stage III melanoma with BRAF V600E/K mutations and pathologic involvement of regional lymph node(s). Patients were randomized to receive TAFINLAR 150 mg twice daily + MEKINIST 2 mg once daily (n=438) or 2 placebos (n=432) for up to 1 year. Enrollment required complete resection of melanoma with complete lymphadenectomy within 12 weeks prior to randomization. None of the patients had undergone previous systemic anticancer treatment or radiotherapy for melanoma. The primary end point was relapse-free survival, defined as the time from randomization to disease recurrence (local, regional, or distant metastasis), new primary melanoma, or death from any cause, whichever occurred first as assessed by the investigator. Secondary end points included overall survival, distant metastasis-free survival, freedom from relapse, and safety.^4-6

Resources

TAFINLAR + MEKINIST Adjuvant Efficacy Videos

Watch as melanoma thought leaders present adjuvant data from the TAFINLAR + MEKINIST clinical trials.

NEXT: Resources

References: 1. Mehnert JM, Kluger HM. Driver mutations in melanoma: lessons learned from bench-to-bedside studies. Curr Oncol Rep. 2012;14(5):449-457. 2. Barbour AP, Tang YH, Armour N, et al. BRAF mutation status is an independent prognostic factor for resected stage IIIB and IIIC melanoma: implications for melanoma staging and adjuvant therapy. Eur J Cancer. 2014;50(15):2668-2676. 3. Dummer R, Hauschild A, Santinami M, et al. Five-year analysis of adjuvant dabrafenib plus trametinib in stage III melanoma. N Engl J Med. 2020;383(12):1139-1148. 4. Long GV, Hauschild A, Santinami M, et al. Adjuvant dabrafenib plus trametinib in stage III BRAF-mutated melanoma. N Engl J Med. 2017;377(19):1813-1823. 5. Tafinlar. Prescribing information. Novartis Pharmaceuticals Corp. 6. Mekinist. Prescribing information. Novartis Pharmaceuticals Corp. 7. Data on file. COMBI-AD Adverse Event Documentation. RITM2419303. Novartis Pharmaceuticals Corp; March 30, 2021. 8. Data on file. Adverse event kinetics in patients treated with dabrafenib + trametinib in the metastatic and adjuvant setting. Novartis Pharmaceuticals Corp; 2019. 9. Braftovi. Prescribing information. Array BioPharma Inc. 10. Mektovi. Prescribing information. Array BioPharma Inc. 11. Cotellic. Prescribing information. Genentech Inc. 12. Zelboraf. Prescribing information. Genentech Inc.

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